Cleared Traditional

K903577 - DYNATRON 200 MICROCURRENT

K903577 is an FDA 510(k) clearance for DYNATRON 200 MICROCURRENT, manufactured by Dynatronics Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K903577 · Dynatronics Corp. · Neurology device
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Mar 1991
Decision
219d
Days
Class 2
Risk

K903577 is an FDA 510(k) clearance for the DYNATRON 200 MICROCURRENT. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 219 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K903577

510(k) Number K903577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date March 15, 1991
Days to Decision 219 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 149d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 421
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K903577.
GLOBALCARE MICRO 11 AND MICROCARE (TENS)
K903394 · Globalcare Intl., Inc. · May 1991
DIAL-AWAY PAIN
K904457 · R.F.P., Inc. · Apr 1991
MC II (TM), MODEL 7200S
K903161 · Medical Devices, Inc. · Mar 1991
SYNAPS (TM)
K903828 · Henley Intl. · Jan 1991
STIMTRAC PC, CATALOG NO. 78-8510
K903128 · Stimtech Products · Jan 1991
MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
K902822 · Medical Design & Manufacturing Corp. · Dec 1990
K903577 · DYNATRON 200 MICROCURRENT
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